Devices
FDA has published two guidances relating to making benefit/risk determinations in certain medical device applications. The first guidance, Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions, describes the agency’s current approach to considering uncertainty in making
Devices
FDA has cleared a 4Web Medical 510(k) to market its Cervical Spine Truss System-Stand Alone interbody fusion device. It is designed to allow fixation screws to be placed through the truss implant and into the adjacent vertebral bodies creating a zero-profile stand-alone construct that removes the
Devices
FDA has cleared a Biobeat 510(k) for its patch and watch for measuring blood pressure, oxygenation and heart rate in hospitals, clinics, long-term care and at home. The company’s smartwatch and patch connect to the cloud through either a smartphone or a dedicated gateway. Users can wear
Devices
FDA has given Staar Surgical IDE approval to begin a clinical trial for the EVO/EVO+ VISIAN Implantable Collamer Lens for myopia, and EVO/EVO+ VISIAN Toric Implantable Collamer Lens for myopia with astigmatism. Under the IDE, FDA recommended study design modifications, which Staar says it plans to incorporate into
Devices
FDA has cleared a Vyaire Medical 510(k) for two of its latest pulmonary function testing (PFT) technologies: Vyntus ONE and Vyntus BODY with SentrySuite Software. Vyntus ONE is designed to be a convenient PFT station available in a fixed or mobile configuration, the company says, and Vyntus BODY is
Devices
FDA has granted Miracor Medical a breakthrough device designation for its PiCSO Impulse System for treating ST-elevated myocardial infarction patients. PiCSO therapy is intended to be provided by interventional cardiologists during percutaneous coronary intervention in patients experiencing ST-elevated myocardial infarction. It works by clearing the coronary microcirculation by
Devices
FDA has cleared a Drawbridge Health 510(k) for the OneDraw A1C Test System, which comprises the OneDraw Blood Collection Device and the OneDraw A1C Test. The device is intended for collecting and stabilizing blood and measurement of HbA1c levels for monitoring long-term blood sugar control in people with
Devices
Medline Industries has recalled its Medline Primary Warmer Pack because it contains the recalled Becton Dickinson Alaris Infusion Sets for the Alaris Pump Model 8100. The pump has been associated with faster-than-expected delivery of medication (over-infusion) or an unintended delivery that occurs while the pump is not
Devices
Edwards Lifesciences has recalled its Sapien 3 Ultra Delivery System due to balloon bursts during surgery, which may result in vascular injury, bleeding, or necessary surgical intervention. The device is part of the Sapien 3 Transcatheter Heart Valve System, which is indicated for use in patients with severe, symptomatic, aortic
Devices
CDRH is listing its 10 current regulatory science priorities that “serve as a catalyst to improve the safety, effectiveness, performance, and quality of medical devices and radiation-emitting products, and to facilitate introducing innovative medical devices into the marketplace.” An online list gives the 10 as: * leverage “Big Data” for
Devices
FDA has cleared a SurGenTec 510(k) for a neurostimulation indication for their Alara Neuro Access Needle Kit. The device is used for targeting and assisting in cannulating a pedicle. Targeting needles are generally the first instrument used to perforate the pedicle wall before advancing a guidewire, tap or pedicle
Devices
National Center for Health Research president Diana Zuckerman says an FDA decision to allow some medical device manufacturers to submit summary reports of adverse events through a hidden Alternate Summary Reporting database was “very inappropriate and unfair to patients and physicians.” As reported online by Cancer Therapy Advisor, Zuckerman said
Devices
BioElectronics has filed a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy, a drug free, over-the-counter device seeking an indication for “adjunctive treatment of musculoskeletal complaints pain.” The device is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and
Devices
A 1/28-2/15 FDA inspection at Polymer Technology Systems, Indianapolis, IN, found Quality System Regulation and other violations in the firm’s manufacturing of in vitro medical devices designed for point-of-care diagnosis and management of diabetes, heart disease, kidney function, and other chronic diseases. A 7/
Devices
FDA has approved a Boston Scientific PMA supplement for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation System to be used in a full-body magnetic resonance imaging (MRI) device. The device is designed to treat the symptoms of Parkinson’s Disease by delivering targeted electrical stimulation
Devices
FDA has cleared an OrthoPediatrics 510(k) for its new PediFoot Deformity Correction System, which the company describes as the first pediatric-specific system to treat fractures and deformities of the foot and ankle. The device is intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small
Devices
FDA has approved Zimmer Biomet Spine’s The Tether – Vertebral Body Tethering System, the first spinal tether device intended to be used in children and adolescents to correct the most common form of scoliosis (idiopathic scoliosis) that has not responded to conservative treatment options, such as external bracing. It is
Devices
FDA has approved an expanded indication for several transcatheter heart valves to include patients with severe aortic valve stenosis (a narrowing of the heart’s aortic valve that restricts blood flow) who are at low risk for death or major complications associated with open-heart surgery to replace the damaged
Devices
FDA and the other members of the Medical Device Innovation Consortium (MDIC) are seeking public comment until 9/13 on the group’s white paper “Best Practices for Communicating Benefit, Risk, and Uncertainty.” An MDIC notice (includes a link to the white paper) says the paper will be part of
Devices
FDA has granted V-Wave a breakthrough device designation for its interatrial shunt for heart failure (HF). The implanted interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal trial called RELIEVE-HF. The study is enrolling advanced HF patients with preserved or reduced left
Devices
FDA has cleared Pollogen’s radiofrequency (RF) home-use device TriPollar Stop for treating the face and the neck to eliminate aging signs, reduce lines and wrinkles and improve skin strength, texture and elasticity. The device uses Pollogen’s triple-axis RF waves to introduce heat to the dermis, which
Devices
Forbes Technology Council member Charles Aunger is questioning whether FDA is the appropriate agency to exercise regulatory authority over artificial intelligence/machine learning (AI/ML)-based software as a medical device. Writing in a Forbes online post, Aunger says FDA has released a proposed framework and stated its intention to